This information collection request captures the requirements of Section 505 of the Food, Drug, and Cosmetic Act, which requires that a new drug may not be marketed unless the manufacture provides FDA with scientific evidence that the drug is both safe and effective. The regulations at 21 CFR Part 314 provide the means through which pharmaceutical manufacturers can obtain FDA approval of a drug product marketing application, and the means through which FDA can assure the safety and effectiveness of the marketed products.
2014-09-30-04:00
Active
Eliazabeth
Berbakos
3018271482
No
No
No
70315
3466039
0
314.50 (a), (b), (c), (d), (e), (f), and (k)
No
Health
Public Health Monitoring
Private Sector
92
241542
0
314.50(i) and 314.94(a)(12)
No
Health
Public Health Monitoring
Private Sector
923
1846
0
314.50(j)
No
Health
Public Health Monitoring
Private Sector
285
572
0
314.52 and 314.95
No
Health
Public Health Monitoring
Private Sector
260
4160
0
314.60
No
Health
Public Health Monitoring
Private Sector
7564
605120
0
314.65
No
Health
Public Health Monitoring
Private Sector
12
24
0
314.70 and 314.71
No
Health
Public Health Monitoring
Private Sector
3050
457500
0
314.72
No
Health
Public Health Monitoring
Private Sector
310
620
0
314.81(b)(1) [3331]
No
Health
Public Health Monitoring
Private Sector
378
3024
0
314.81(b)(2) [2252]
No
Health
Public Health Monitoring
Private Sector
8149
362892
0
314.81(b)(3)(i) [2253]
No
Health
Public Health Monitoring
Private Sector
30130
60260
0
314.94(a)(1)-(11) and (d)
No
Health
Public Health Monitoring
Private Sector
862
413760
0
314.96
No
Health
Public Health Monitoring
Private Sector
10461
836880
0
314.97
No
Health
Public Health Monitoring
Private Sector
5169
413520
0
314.99(a)
No
Health
Public Health Monitoring
Private Sector
122
244
0
314.101(a)
No
Health
Public Health Monitoring
Private Sector
1
1
0
314.107(c)
No
Health
Public Health Monitoring
Private Sector
230
115
0
314.107(e)
No
Health
Public Health Monitoring
Private Sector
98
49
0
314.107(f)
No
Health
Public Health Monitoring
Private Sector
230
115
0
314.110(a)(5)
No
Health
Public Health Monitoring
Private Sector
1
1
0
314.110(c)
No
Health
Public Health Monitoring
Private Sector
15
8
0
314.420
No
Health
Public Health Monitoring
Private Sector
1038
63318
0
Guidance; Reports on the Status of Postmarketing Studies/Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997
No
Health
Health Care Services
Private Sector
935
468
0
2011-09-05-04:00
0910-0014
201105-0910-011
0910
"Investigational New Drug Regulations"
Information collection from applicants who apply for approval of an investigational new drug application in order to develop a drug for marketing.
2015-04-30-04:00
Active
Eliazabeth
Berbakos
3018271482
No
No
No
2685772
141870849
0
312.2(e) Request for advice on applicability of part 312
No
Health
Consumer Health and Safety
Private Sector
469
11256
0
312.10 Applications for waiver of requirements under part 312
No
Health
Consumer Health and Safety
Private Sector
4
40
0
312.23 Investigational New Drug submission
No
Health
Consumer Health and Safety
Private Sector
3145
5032000
0
312.30(a)-(e) Protocol Amendments
No
Health
Consumer Health and Safety
Private Sector
18079
5134436
0
312.31(b) Information Amendments
No
Health
Public Health Monitoring
Private Sector
454
45400
0
312.32(c)-(d) Safety Reports
No
Health
Public Health Monitoring
Private Sector
22713
726816
0
312.33 Annual Reports
No
Health
Public Health Monitoring
Private Sector
6000
2160000
0
312.8 Charging for investigational drugs under an IND
No
Health
Public Health Monitoring
Private Sector
34
1632
0
312.310(b) and 312.305(b) Submissions related to expanded access and treatment of an individual
No
Health
Public Health Monitoring
Private Sector
988
7904
0
312.38(b)(c) Notification of withdrawal of an IND
No
Health
Public Health Monitoring
Private Sector
874
24472
0
312.42(e) Request to remove clinical hold
No
Health
Public Health Monitoring
Private Sector
164
46576
0
312.44(c)(d) Response to termination of IND
No
Health
Public Health Monitoring
Private Sector
44
704
0
312.45(a)(b) Request for or response to inactive status determination
No
Health
Public Health Monitoring
Private Sector
362
4344
0
312.47(b) End-of-Phase 2 and Pre-NDA meetings
No
Health
Public Health Monitoring
Private Sector
506
80960
0
312.53(c) Investigator Information
No
Health
Public Health Monitoring
Private Sector
21194
1695520
0
312.54(a)(b) Submissions concerning exception from informed consent under 50.24
No
Health
Public Health Monitoring
Private Sector
1
48
0
312.55(b) Sponsor reports on new observations, e.g. adverse reactions and safe use
No
Health
Public Health Monitoring
Private Sector
2271300
109022400
0
312.56(b)(c)(d) Sponsor monitoring of investigations;notifications to FDA
No
Health
Public Health Monitoring
Private Sector
18
1440
0
312.58(a) Submission of records to FDA
No
Health
Public Health Monitoring
Private Sector
373
2984
0
312.64 Investigator reports to the sponsor
No
Health
Public Health Monitoring
Private Sector
31791
762984
0
312.70(a) Investigator disqualification; opportunity to respond
No
Health
Public Health Monitoring
Private Sector
4
160
0
312.110(b) Request to export and investigational drug
No
Health
Public Health Monitoring
Private Sector
420
31500
0
312.120 Submissions related to foreign clinical studies not conducted under an IND
No
Health
Public Health Monitoring
Private Sector
575
18400
0
312.130(d) Request for disclosable information for investigations involving an exception from informed consent
No
Health
Public Health Monitoring
Private Sector
3
24
0
312.52(a) Transfer of obligations to a contract research organization
No
Health
Public Health Monitoring
Private Sector
503
1006
0
312.57 Sponsor recordkeeping
No
Health
Public Health Monitoring
Private Sector
36396
3639600
0
312.62(a) Investigator recordkeeping of disposition of drugs
No
Health
Public Health Monitoring
Private Sector
14732
589280
0
312.62(b) Investigator recordkeeping of case histories of individuals
No
Health
Public Health Monitoring
Private Sector
147320
5892800
0
312.60(a)(3)Records of shipment of drugs for investigational use in laboratory research animals or in vitro tests
No
Health
Public Health Monitoring
Private Sector
782
391
0
312.160(c) Shipper records of alternative disposition of unused drugs
No
Health
Public Health Monitoring
Private Sector
782
391
0
312.8 Biologics; Charging for investigational drugs under an IND
No
Health
Public Health Monitoring
Private Sector
57
1368
0
312.23 and 312.120(b)(c)(2)(c)(3). Biologics; Investigational New Drug Submission
No
Health
Public Health Monitoring
Private Sector
563
1017904
0
312.30(a)-(e) Biologics; Protocol Amendments
No
Health
Public Health Monitoring
Private Sector
4012
1139408
0
312.31(b) Biologics; Information amendments
No
Health
Public Health Monitoring
Private Sector
7706
770600
0
312.32(c)(d) and 312.56(c) Biologics; Safety Reports and Notifications
No
Health
Public Health Monitoring
Private Sector
4028
128896
0
312.33(a) -(f) and 312.56(c) Biologics; Annual reports and related notifications
No
Health
Public Health Monitoring
Private Sector
1488
535680
0
Investigational New Drug Regulations
No
Health
Public Health Monitoring
Private Sector
0
0
0
Investigational New Drug Regulations
No
Health
Public Health Monitoring
Private Sector
0
0
0
312.38(b)(c) Biologics; Notification of withdrawal of an IND
No
Health
Public Health Monitoring
Private Sector
152
4256
0
312.42(e) Biologics; Request to remove clinical hold
No
Health
Public Health Monitoring
Private Sector
111
31524
0
312.44(c) and (d) Biologics; Response to termination of IND
No
Health
Public Health Monitoring
Private Sector
18
304
0
312.45(a) and (b) Biologics; Request for or response to inactive status determination
No
Health
Public Health Monitoring
Private Sector
108
1296
0
312.47(b) Biologics; End-of-Phas 2 and Pre-NDA meetings
No
Health
Public Health Monitoring
Private Sector
65
10400
0
312.53(c) Biologics; Investigator Information
No
Health
Public Health Monitoring
Private Sector
2297
183760
0
312.54(a) and (b) Biologics; Submissions concerning exception from informed consent under 50.24
No
Health
Public Health Monitoring
Private Sector
1
48
0
312.55(b) Biologics; Sponsor reports on new observations; e.g. adverse reactions and safe use
No
Health
Public Health Monitoring
Private Sector
345
16560
0
312.56(b) and (d) Biologics; Sponsor monitoring of clinical investigations; notification to FDA
No
Health
Public Health Monitoring
Private Sector
22
1760
0
312.58(a) Biologics; Sponsor submission of records
No
Health
Public Health Monitoring
Private Sector
8
64
0
312.64 Investigator Reports to the sponsor
No
Health
Public Health Monitoring
Private Sector
21010
504240
0
312.70(a) Biologics; Investigator disqualification - opportunity to respond
No
Health
Public Health Monitoring
Private Sector
6
240
0
312.110(b) Request to export an investigational drug
No
Health
Public Health Monitoring
Private Sector
21
1575
0
312.130(d) Biologics; Request for disclosable information for investigations involving an exception from informed consent
No
Health
Public Health Monitoring
Private Sector
1
8
0
312.52(a) Biologics; Transfer of obligations to a contract research organization
No
Health
Public Health Monitoring
Private Sector
195
390
0
312.57(a)(b) Biologics; Sponsor recordkeeping
No
Health
Public Health Monitoring
Private Sector
1126
112600
0
312.62(a) Biologics; Investigator recordkeeping of disposition of drugs
No
Health
Public Health Monitoring
Private Sector
5570
222800
0
312.62(b) Biologics; Investigator recordkeeping of case histories of individuals
No
Health
Public Health Monitoring
Private Sector
55700
2228000
0
312.160(a)(3) Biologics; Records maintenance: shipment of drugs for investigational use in laboratory research animals or in vitro tests
No
Health
Public Health Monitoring
Private Sector
204
102
0
312.160(c) Biologics; Shipper records of alternative disposition of unused drugs
No
Health
Public Health Monitoring
Private Sector
204
102
0
312.310(d) Emergency use of an investigational new drug
No
Health
Public Health Monitoring
Private Sector
646
10336
0
312.315(c) and 312.305 (b) Submissions related to expanded access and treatment of an individual patient.
No
Health
Public Health Monitoring
Private Sector
68
8160
0
312.320 Submissions related to treatment IND or treatment protocol
No
Health
Public Health Monitoring
Private Sector
10
3000
0
2012-04-16-04:00
0910-0016
201104-0910-003
0910
"Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504"
Currently, interested persons may transmit regulatory submissions to the Office of Food Additivie Safety in the Center for Food Safety and Applied Nutrition using Form FDA 3504 for color additive petitions. FDA is revising Form FDA 3503 to better enable its use for electronic submission and to permit its use for multiple types of submissions, which eliminates the need for Form FDA 3504. This action is a consolidation of Form FDA 3504 under Form FDA 3503, which after OMB approval for this request Form FDA 3504 will be discontinued. In summary, the revised Form FDA 3503 will be used for food additive and color additive petitions.
2014-06-30-04:00
Active
Denver
Presley
3018271462
No
No
No
12
26573
5600
Submission of Petitions, Color Additive Including Labeling
No
Health
Consumer Health and Safety
3503
Food Additive; Color Additive Petition; Food Master File; Color Master File
Yes
Yes
Fillable Printable
Form
Revised Draft Form FDA 3503 for 2010.pdf
Yes
No
Printable Only
Other
Instructions - Revised Draft Form FDA 3503.pdf
Private Sector
2
2674
5600
Submission of Petitions Generally Recognized As Safe Affirmation
No
Health
Consumer Health and Safety
3503
Food additive Petition; Color Additive Petition;; Food Master File; Color Master File
Yes
Yes
Fillable Printable
Form
Revised Draft Form FDA 3503 for 2010.pdf
Yes
Yes
Printable Only
Instruction
Instructions - Revised Draft Form FDA 3503.pdf
Private Sector
1
2614
0
Submission of Petitions: Food Additive Including Labeling
No
Health
Consumer Health and Safety
3503
Food additive Petition; Color Additive Petition; Food Master File; Color Master file
Yes
Yes
Fillable Printable
Form
Revised Draft Form FDA 3503 for 2010.pdf
Yes
Yes
Printable Only
Instruction
Instructions - Revised Draft Form FDA 3503.pdf
Private Sector
3
21279
0
Form FDA 3503
No
Health
Consumer Health and Safety
3503
Food Additive Petition; Color Additive Petition; Food Master File; Color Master File
Yes
Yes
Fillable Printable
Form
Revised Draft Form FDA 3503 for 2010.pdf
Yes
Yes
Printable Only
Instruction
Instructions - Revised Draft Form FDA 3503.pdf
Private Sector
6
6
0
2011-06-27-04:00
0910-0021
201303-0910-004
0910
"Interstate Shellfish Dealer's Certificate"
The information collected is used to compile, publish, and distribute a listing of approved sources of state and international certified shellfish dealers/shippers. Food control officials and the food industry use the list to determine certified sources of shellfish.
2016-05-31-04:00
Active
Domini
Bean
domini.bean@fda.hhs.gov
301 796-5733
No
No
No
2280
228
0
Interstate Shellfish Dealer's Certificate
No
Health
Consumer Health and Safety
FDA Form 3038
Interstate Shellfish Dealer's Certificate
Yes
Yes
Fillable Fileable
Form
FDA Form3038 Shellfish-proposed.pdf
State, Local, and Tribal Governments
2280
228
0
2013-05-23-04:00
0910-0025
201311-0910-008
0910
"Reporting and Recordkeeping for Electronic Products - General Requirements"
To protect the public from unnecessary exposure to radiation from electronic products, FDA must collect certain information from manufacturers and dealers/distributors about electronic products they sell or install. This ICR collects information from electronic product and x-ray manufacturers, importers, and assemblers. These respondents report and maintain information related to the identification of, location of, operational characteristics of, quality assurance programs for, and problem identification and correction of electronic products. The data reported to the Food and Drug Administration (FDA) and the records maintained are used by FDA and industry to make decisions and take actions that protect the public from radiation hazards presented by electronic products. The information collections are either specifically called for in legislation or were developed to aid FDA in performing its obligations under legislation.
2017-01-31-05:00
Active
JonnaLynn
Capezzuto
jonnalynn.capezzuto@fda.hhs.gov
301 827-4659
No
No
No
2846697
516974
0
Reporting for Electronic Products: General Requirements
No
Health
Consumer Health and Safety
FDA 3628
General Med X-ray annual report (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3628 esubmitter Med X-Ray Annual Blank Form.pdf
FDA 3663
Microwave products (non-oven) (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3663 esubmitter Abbrev Microwave Blank.pdf
FDA 3662
Cephalometric device (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3662 esubmitter Cephalometric Blank form.pdf
FDA 3661
X-ray tables, etc (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3661 esubmitter Abbrev X-Ray Blank form.pdf
FDA 3629
General abbreviated report (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3629 esubmitter Abbreviated Blank Form.pdf
FDA 3801
UV lamps (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3801 esubmitter Medical UV Lamps Blank.pdf
FDA 3660
Microwave oven (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3660 esubmitter MWO Blank form.pdf
FDA 3626
Diagnostic X-Ray
Yes
Yes
Fillable Fileable
Form and instruction
3626 pdf D X-Ray BlankForm.pdf
FDA 3659
TV (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3659 esubmitter TV Blank form.pdf
FDA 3644
Ultrasonic therapy (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3644 esubmitter Therapy Ultrasound Blank.pdf
FDAS 3646
Mercury vapor lamp (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3646 esubmitter Mercury Vapor Blank form.pdf
FDA 3630
Sunlamp (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3630 esubmitter Sunlamp Blank form.pdf
FDA 3630
Sunlamp
Yes
Yes
Fillable Fileable
Form and instruction
3630 pdf Sunlamp Blank form.pdf
FDA 3640
Laser Light Show (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3640 esubmitter LLS Show Blank form.pdf
FDA 3640
Laser Light Show
Yes
Yes
Fillable Fileable
Form and instruction
3640 pdf LLS Show Blank form.pdf
FDA 3632
Laser (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3632 esubmitter Laser Blank form.pdf
FDA 3632
Laser
Yes
Yes
Fillable Fileable
Form and instruction
3632 pdf Laser Blank form.pdf
FDA 3639
Cabinet X-Ray (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3639 esubmitter Cab X-Ray blank form.pdf
FDA 3627
CT X-Ray (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3627 esubmitter DX CT Blank form.pdf
FDA 3627
CT X-Ray
Yes
Yes
Fillable Fileable
Form and instruction
3627 pdf DX CT Blank form.pdf
FDA 3626
Diagnostic X-Ray (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3626 esubmitter D X-Ray BlankForm.pdf
FDA 3638
Diagnostic X-ray annual report (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3638 esubmitter X-Ray Annual.pdf
FDA 3634
TV annual report (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3634 esubmitter TV Annual Blank Form.pdf
FDA 3641
Cabinet x-ray annual report (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3641 esubmitter Cab X-Ray Blank Form.pdf
FDA 3643
MIcrowave oven annual report
Yes
Yes
Fillable Fileable
Form and instruction
3643 esubmitter MWO Annual Blank Form.pdf
FDA 3636
Laser annual report (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3636 esubmitter Laser Annual Blank Form.pdf
FDA 3631
Sunlamp annual report (esubmitter)
Yes
Yes
Fillable Fileable
Form and instruction
3631 esubmitter Sunlamp Annual Blank Form.pdf
Private Sector
53392
81460
0
Recordkeeping for Electronic Products: General Requirements
No
Health
Consumer Health and Safety
Private Sector
2790100
324375
0
Third party disclosure for Electronic Products: General Requirements
No
Health
Consumer Health and Safety
Private Sector
3205
111139
0
2014-01-03-05:00
0910-0027
201102-0910-012
0910
"Voluntary Cosmetic Registration Program"
The "Voluntary Cosmetic Registration Program" provides FDA with the best information available about the locations, business trade names, and types of activity (manufacturing and packaging) of establishment that participate in this program. FDA uses the registration to estimate the size of the cosmetic industry and for conducting on site establishment inspections.
2014-04-30-04:00
Active
Denver
Presley
3018271462
No
No
No
7525
1827
0
Reporting - 21 CFR Part 710 - Voluntary Registration of Cosmetics Product Establishment
No
Health
Consumer Health and Safety
FDA 2511
Registration of Cosmetic Product Establishment
http://www.cfsan.fda.gov/~dms/cos-reg2.html
Yes
Yes
Fillable Printable
Form and instruction
0027 FDA Form 2511.doc
Private Sector
135
27
0
Reporting - 21 CFR- 720.1 - 720.4 - Voluntary Registration ( New submissions
No
Health
Consumer Health and Safety
2512 a
Cosmetic Product Ingredient
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 2512a.pdf
2512
Cosmetic Product Ingredient Statement
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 2512.pdf
Private Sector
4371
1442
0
Reporting 21 CFR 720.6 Voluntary Registration ( Amendments)
No
Health
Consumer Health and Safety
2512a
Cosmetic Product Ingredient
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 2512a.pdf
2512
Cosmetic Product Ingredient statement
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 2512.pdf
Private Sector
763
130
0
Reporting 21CFR 720.6 Voluntary Registration ( Notices of Discontinuance)
No
Health
Consumer Health and Safety
2514
Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 2514.pdf
Private Sector
2255
226
0
Reporting 21 CFR 720.8 Voluntary Registration ( Request for Confidentiality)
No
Health
Consumer Health and Safety
Private Sector
1
2
0
2011-04-29-04:00
0910-0032
201305-0910-003
0910
"New Animal Drug Application, 21 CFR Part 514"
Certain information that submitted as part of a New Animal Drug Application (NADA) must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of new animal drugs in edible tissues from food producing animals.
2016-07-31-04:00
Active
Domini
Bean
domini.bean@fda.hhs.gov
301 796-5733
No
No
No
1367
28218
0
Requesting presubmission conferences
No
Health
Consumer Health and Safety
Private Sector
69
3450
0
Applications and amended applications
No
Health
Consumer Health and Safety
Private Sector
12
2544
0
Manufacturing changes to an approved application
No
Health
Consumer Health and Safety
Private Sector
375
13125
0
Labeling and other changes to an approved application
No
Health
Consumer Health and Safety
Private Sector
10
710
0
Labeling and other changes to an approved application
No
Health
Consumer Health and Safety
Private Sector
121
2420
0
Submission of data, studies, and other information
No
Health
Consumer Health and Safety
Private Sector
14
14
0
Requirements for liquid medicated feed
No
Health
Consumer Health and Safety
Private Sector
2
10
0
Evidence to establish safety and effectiveness
No
Health
Consumer Health and Safety
Private Sector
25
2250
0
Form FDA 356V
No
Health
Consumer Health and Safety
FDA 356V
Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)
Yes
Yes
Fillable Fileable
Form and instruction
0032 FDA356V 5-1-13 ICR.pdf
Private Sector
739
3695
0
2013-07-02-04:00
0910-0037
201106-0910-005
0910
"Food Canning Establishment Registration, Process Filing and Recordkeeping for Acidified and Thermally Processed Low-Acid Foods"
The information is necessary to ensure safe manufacturing, processing, and packing procedures and to permit FDA to verify that these procedures are being followed.
2015-02-28-05:00
Active
Denver
Presley
3018271462
No
No
No
86878
2380467
0
Reporting: Food Canning Establishment Registration for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541
No
Health
Consumer Health and Safety
FDA-2541
FDA-2541
Yes
No
Fillable Printable
Form and instruction
FDA-2541.pdf
1
Register Food Canning Establishment
Yes
No
Fillable Printable
Form and instruction
Register Food Canning Establishment.pdf
Private Sector
515
88
0
Reporting: - Food Canning Establishment, Process Filing for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers - Form FDA 2541 a
No
Health
Consumer Health and Safety
2541a
Process Filing For All Methods Except Low - Acid Aseptic
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 2541a Process Filing.pdf
Private Sector
12835
4274
0
Reporting: Food Canning Establishment , Food Process Filing for Low Acid Aseptic Systems - Form FDA 2541c
No
Health
Consumer Health and Safety
2541c
Food Processing for Low Acid Aseptic
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 2541 c ( aseptic systems).pdf
Private Sector
653
490
0
Recordkeeping: 21 CFR 113 and 114 - Food Canning Establishment Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Food in Hermetically Sealed Containers
No
Health
Consumer Health and Safety
Private Sector
9500
2375000
0
Recordkeeping: 21 CFR 113.100 ( C ) and ( d ) - Food Canning Establishment Temperature Indicating Devices : Thermally Processed Low - Acid Foods Packaged in Hermetically Sealed Containers
No
Health
Consumer Health and Safety
Private Sector
63375
615
0
2012-02-27-05:00
0910-0045
201203-0910-007
0910
"Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution"
21 CFR part 207 implements section 510 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360), under which FDA is authorized to establish a system for registration of producers of drugs and for listing of drugs in commercial distribution.
2015-08-31-04:00
Active
Johnny
Vilela
juanmanuel.vilela@fda.hhs.gov
301 796-3792
No
No
No
45168
227222
0
June and December updates of all drug listing information
No
Health
Consumer Health and Safety
FDA Form 2658
Registered Establishment
No
No
Paper Only
Form
FDA-2658.pdf
No
No
Paper Only
Other
Reg and list final guid 12-5-08 to OMB.doc
FDA Form 2657
Drug Product Listing (New Drug Listing)
No
No
Paper Only
Form
FDA-2657.pdf
No
No
Paper Only
Instruction
form2656.htm
No
No
Paper Only
Instruction
2658instruc..htm
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
No
No
Paper Only
Form
FDA-2656.doc
Private Sector
18799
84596
0
New registrations, including new labeler codes requests
No
Health
Consumer Health and Safety
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
No
No
Paper Only
Form
FDA-2656.doc
FDA Form 2658
Registered Establishment
No
No
Paper Only
Form
FDA-2658.pdf
No
No
Paper Only
Other
Reg and list final guid 12-5-08 to OMB.doc
FDA Form 2657
Drug Product Listing (New Drug Listing)
No
No
Paper Only
Form
FDA-2657.pdf
No
No
Paper Only
Instruction
form2656.htm
No
No
Paper Only
Instruction
2658instruc..htm
Private Sector
574
2583
0
Annual updates of registration information
No
Health
Consumer Health and Safety
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
No
No
Paper Only
Form
FDA-2656.doc
FDA Form 2658
Registered Establishment
No
No
Paper Only
Form
FDA-2658.pdf
No
No
Paper Only
Instruction
2658instruc..htm
No
No
Paper Only
Instruction
form2656.htm
FDA Form 2657
Drug Product Listing (New Drug Listing)
No
No
Paper Only
Form
FDA-2657.pdf
No
No
Paper Only
Other
Reg and list final guid 12-5-08 to OMB.doc
Private Sector
9735
43808
0
New drug listings
No
Health
Consumer Health and Safety
FDA Form 2657
Drug Product Listing (New Drug Listing)
No
No
Paper Only
Form
FDA-2657.pdf
No
No
Paper Only
Instruction
2658instruc..htm
No
No
Paper Only
Other
Reg and list final guid 12-5-08 to OMB.doc
FDA Form 2658
Registered Establishment
No
No
Paper Only
Form
FDA-2658.pdf
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
No
No
Paper Only
Form
FDA-2656.doc
No
No
Paper Only
Instruction
form2656.htm
Private Sector
10295
46328
0
New listings for private label distributor
No
Health
Consumer Health and Safety
No
No
Paper Only
Other
Reg and list final guid 12-5-08 to OMB.doc
FDA Form 2658
Registered Establishment
No
No
Paper Only
Form
FDA-2658.pdf
No
No
Paper Only
Instruction
form2656.htm
No
No
Paper Only
Instruction
2658instruc..htm
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
No
No
Paper Only
Form
FDA-2656.doc
FDA Form 2657
Drug Product Listing (New Drug Listing)
No
No
Paper Only
Form
FDA-2657.pdf
Private Sector
1469
6611
0
Waiver requests
No
Health
Consumer Health and Safety
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
No
No
Paper Only
Form
FDA-2656.doc
FDA Form 2658
Registered Establishment
No
No
Paper Only
Form
FDA-2658.pdf
No
No
Paper Only
Instruction
2658instruc..htm
FDA Form 2657
Drug Product Listing (New Drug Listing)
No
No
Paper Only
Form
FDA-2657.pdf
No
No
Paper Only
Other
Reg and list final guid 12-5-08 to OMB.doc
No
No
Paper Only
Instruction
form2656.htm
Private Sector
1
1
0
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
No
Health
Consumer Health and Safety
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
No
No
Paper Only
Form
FDA-2656.doc
FDA Form 2658
Registered Establishment
No
No
Paper Only
Form
FDA-2658.pdf
No
No
Paper Only
Instruction
2658instruc..htm
No
No
Paper Only
Instruction
form2656.htm
FDA Form 2657
Drug Product Listing (New Drug Listing)
No
No
Paper Only
Form
FDA-2657.pdf
No
No
Paper Only
Other
Reg and list final guid 12-5-08 to OMB.doc
Private Sector
1000
40000
0
SOP maintenance
No
Health
Consumer Health and Safety
No
No
Paper Only
Instruction
2658instruc..htm
FDA Form 2658
Registered Establishment
No
No
Paper Only
Form
FDA-2658.pdf
FDA Form 2656
Registration of Drug Establishment (New registration, including new labeler codes for private label distributor)
No
No
Paper Only
Form
FDA-2656.doc
FDA Form 2657
Drug Product Listing (New Drug Listing)
No
No
Paper Only
Form
FDA-2657.pdf
No
No
Paper Only
Other
Reg and list final guid 12-5-08 to OMB.doc
No
No
Paper Only
Instruction
form2656.htm
Private Sector
3295
3295
0
2012-08-15-04:00
0910-0046
201102-0910-009
0910
"Electronic Importer's Entry Notice"
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control Act amended the Federal, Food, Drug, and Cosmetic Act (FD&C Act) by adding a new chapter granting the Food and Drug Administration (FDA) important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.
With the passage of the Tobacco Control Act, section 801 of the FD&C Act was amended to add tobacco products to the inventory of FDA-regulated products. The new section 801 charges the Secretary of Health and Human Services (HHS), through the FDA, with the responsibility of assuring foreign origin FDA regulated foods, drugs, cosmetics, medical devices, radiological health, and tobacco products offered for import into the United States meet the same requirements of the act as do domestic products, and for preventing products from entering the country if they are not in compliance. The discharge of this responsibility involves close coordination and cooperation between FDA headquarters and field inspectional personnel and the U.S. Customs Service (USCS), as the USCS is responsible for enforcing the revenue laws covering the very same products.
2014-04-30-04:00
Active
Jonnalynn
Capezzuto
3018274659
No
No
No
3722734
521179
0
Electronic Importer's Entry Notice
No
Health
Public Health Monitoring
Private Sector
3722734
521179
0
2011-04-25-04:00
0910-0052
201201-0910-002
0910
"Blood Establishment Registration and Product Lising Form FDA 2830"
Under section 510 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360), any person owning or operating an establishment that manufactures, prepares, propagates, compounds, or processes a drug or device must register with the Secretary of Health and Human Services, on or before December 31 of each year, his or her name, place of business, and all such establishments must submit, among other information, a listing of all drug or device products manufactured, prepared, propagated, compounded, or processed by him or her for commercial distribution. The regulations of establishment registration and product listing for blood establishments are found in 21 CFR Part 607. These establishments are required to submit this information on Form FDA 2830.
2015-03-31-04:00
Active
ILa
Mizrachi
ila.mizrachi@fda.hhs.gov
301 796-7726
No
No
No
2818
1389
0
Initial Registration
No
Health
Consumer Health and Safety
2830
Blood Establishment Registration and Product Listing
Yes
Yes
Printable Only
Form and instruction
FDA-2830 12-2008.doc
Private Sector
49
49
0
Re-registration
No
Health
Consumer Health and Safety
2830
Blood Establishment Registration and Product Listing
Yes
Yes
Printable Only
Form and instruction
FDA-2830 12-2008.doc
Private Sector
2589
1295
0
Product Listing Update
No
Health
Consumer Health and Safety
2830
Blood Establishment Registration and Product Listing
Yes
Yes
Printable Only
Form and instruction
FDA-2830 12-2008.doc
Private Sector
180
45
0
2012-03-08-05:00
0910-0053
201103-0910-012
0910
"Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary"
The information is needed for the collection requirements contained in 21 CFR 361.1. The information will be reviewed to determine the qualifications of the membership and the appropriateness of approved studies. The respondents are the Chairpersons, investigators, and members of the approved Radioactive Drug Research Committees.
2014-05-31-04:00
Active
Eliazabeth
Berbakos
3018271482
No
No
No
1420
4759
0
Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary
No
Health
Illness Prevention
FDA 2914
Membership Summary
No
No
Paper Only
Form
FDA-2914.doc
Private Sector
80
80
0
Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary
No
Health
Illness Prevention
FDA 2915
Study Summary
No
No
Paper Only
Form
FDA-2915.doc
Private Sector
340
1190
0
Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary
No
Health
Illness Prevention
Private Sector
340
34
0
Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary
No
Health
Illness Prevention
FDA 2915
Study Summary
No
No
Paper Only
Form
FDA-2915.doc
Private Sector
320
3200
0
Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drug Study Summary
No
Health
Illness Prevention
FDA 2915
Study Summary
No
No
Paper Only
Form
FDA-2915.doc
Private Sector
340
255
0
2011-05-20-04:00
0910-0073
201312-0910-006
0910
"Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation"
This ICR collects information from medical device manufacturers who must meet the Current Good Manufacturing Practice Quality System (CGMP/QS) requirements for purchasing and service controls; recordkeeping requirements for device failure and complaint investigations; requirements for verifying/validating production processes and process or product changes; and requirements for product acceptance activities, quality data evaluations, and corrections of nonconforming product/quality problems. CGMP/QS information collections assist FDA inspections of manufacturer compliance with quality system requirements encompassing design, production, installation, and servicing processes. Manufacturers must ensure that medical devices meet design specifications and that design specifications are effectively transferred from research and development to production.
2017-02-28-05:00
Active
JonnaLynn
Capezzuto
jonnalynn.capezzuto@fda.hhs.gov
301 827-4659
No
No
No
25986
9043128
0
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation
No
Health
Consumer Health and Safety
Private Sector
25986
9043128
0
2014-02-07-05:00
0910-0078
201301-0910-001
0910
"Investigational Device Exemptions Reports and Records - 21 CFR 812"
The Food and Drug Administration (FDA) is requesting approval from the Office of Management and Budget (OMB) for information collection requirements contained in 21 CFR, Part 812. The IDE regulation permits a device to be shipped in interstate commerce for clinical investigation to determine its medical safety and effectiveness. Although the IDE regulations exempts the device from certain requirements of the Act, it requires safeguards for humans who are subjects of investigations; maintenance of sound ethical standards; and procedures to assure development of reliable scientific data.
2016-03-31-04:00
Active
Daniel
Gitteson
daniel.gitteson@fda.hhs.gov
3017965156
No
No
No
9493
64227
0
Reporting
No
Health
Immunization Management
Private Sector
4631
54253
0
Recordkeeping
No
Health
Immunization Management
Private Sector
4861
9968
0
Third Party Disclosures
No
Health
Immunization Management
Private Sector
1
6
0
2013-03-20-04:00
0910-0114
201302-0910-002
0910
"Administrative Detention and Banned Medical Devices"
The FDA has the statutory authority under section 304(g) of the FD&C Act to detain devices during establishment inspections which are believed to be adulturated or misbranded. On March 9, 1979, FDA issued a final regulation on Administrative Detention Procedures which includes, among other things, certain reporting and recordkeeping requirements. FDA also has the statutory authority under section 516 of the Act to ban devices that present substantial deception, unreasonable and substantial risk of illness or injury, or unreasonable, direct and substantial danger to the health of individuals. Under these authorities there are requirements pertaining to reporting and recordkeeping activities that are necessary in order for the Agency to carry out its mission to protect the public health.
2016-04-30-04:00
Active
Daniel
Gitteson
daniel.gitteson@fda.hhs.gov
3017965156
No
No
No
28
461
0
Administrative Detention and Banned Medical Devices
No
Health
Consumer Health and Safety
Private Sector
28
461
0
2013-04-10-04:00
0910-0116
201201-0910-001
0910
"Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components"
The information collection requirements in the CGMP, donor testing, donor notification, and "lookback" regulations provide FDA with the necessary information to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections. The recordkeeping requirements serve preventative and remedial purposes. The disclosure requirements identify the various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing back of a product to its original source. The reporting requirements inform FDA of any deviations that occur and that may require immediate corrective action.
2015-04-30-04:00
Active
ILa
Mizrachi
ila.mizrachi@fda.hhs.gov
301 796-7726
No
No
No
3206393
506637
0
Reporting burden: adverse reactions and testing
No
Health
Consumer Health and Safety
Private Sector
78
1522
0
Recordkeeping burden: SOPs and maintenance of records
No
Health
Consumer Health and Safety
Private Sector
2672173
443786
0
Third party disclosure: adverse reactions, test requirements, labeling, "lookback" requirements, donor notification
No
Health
Consumer Health and Safety
Private Sector
534142
61329
0
2012-04-09-04:00
0910-0117
201207-0910-001
0910
"New Animal Drugs for Investigational Use"
To gain approval to market an animal drug, the applicant must file a New Animal Drug Application containing data to support the safety and effectiveness of the drug, appropriate labeling, product manufacturing information and where applicable, methods to determine residues of the drug in edible tissue from food producing animals.
2015-10-31-04:00
Active
Denver
Presley
3018271462
No
No
No
5528
12328
0
511.1(b)(4) NCIE for clinical investigations
No
Health
Consumer Health and Safety
3458
Notice of Claimed Investigational Exemption
Yes
Yes
Fillable Printable
Form and instruction
FDA Form 3458.pdf
Private Sector
1238
1238
0
511.1(b)(5) Data submission for use of edible food products
No
Health
Consumer Health and Safety
Private Sector
70
560
0
511.1(b)(6) Information required in order to determine if there are grounds for terminating exemption
No
Health
Consumer Health and Safety
Private Sector
2
2
0
511.1(b)(8) (ii) Report of significant hazards
No
Health
Consumer Health and Safety
Private Sector
15
30
0
511.1(b)(9) Import for clinical investigation
No
Health
Consumer Health and Safety
Private Sector
15
120
0
511.1(a)(3) - Recordkeeping for laboratory research
No
Health
Consumer Health and Safety
Private Sector
474
474
0
511.1(b)(3) - Recordkeeping for clinical investigations
No
Health
Consumer Health and Safety
Private Sector
1238
1238
0
511.1(b)(7)(ii) - Recordkeeping sponsor
No
Health
Consumer Health and Safety
Private Sector
1238
4333
0
511.1(b)(8)(i) - Recordkeeping of investigator reports
No
Health
Consumer Health and Safety
Private Sector
1238
4333
0
2012-10-22-04:00
0910-0119
201107-0910-008
0910
"Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58"
The GLP regulations are intended to assure the quality and integrity of the safety data submitted to FDA in support of the approval of regulated products. The required information will help assure that only safe products are approved for marketing.
2014-09-30-04:00
Active
Johnny
Vilela
juanmanuel.vilela@fda.hhs.gov
301 796-3792
No
No
No
36150
1311157
0
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies - 21 CFR Part 58
No
Health
Public Health Monitoring
Private Sector
36150
1311157
0
2011-09-05-04:00
0910-0120
201311-0910-009
0910
"Premarket Notification Submission 510(k), Subpart E"
This ICR collects information from persons who intend to market a medical device. Based on the information provided in the premarket notification (510(k)) submission, FDA determines whether a new device provides reasonable assurance of the safety and effectiveness of the device through substantial equivalence to a legally marketed device and whether the device can, therefore, be allowed to enter the U.S. market. Because the review of 510(k) submissions confirms that the new device is as safe and as effective as legally marketed predicate devices, potentially unsafe and/or ineffective devices, including those with fraudulent claims, are prevented from entering the U.S. market.
2017-01-31-05:00
Active
JonnaLynn
Capezzuto
jonnalynn.capezzuto@fda.hhs.gov
301 827-4659
No
No
No
9470
336051
0
Premarket Notification Submission 510(k), Subpart E
No
Health
Consumer Health and Safety
FDA 3541
Premarket Notification [510(K)] Status Request and Response
Yes
Yes
Fillable Fileable
Form and instruction
FDA 3541.pdf
FDA 3514
CDRH Premarket Review Coversheet
Yes
Yes
Fillable Fileable
Form and instruction
FDA 3514.pdf
FDA 3654
Standards Data Report for 510(k)s
Yes
Yes
Fillable Fileable
Form and instruction
FDA 3654.pdf
Private Sector
9470
336051
0
2014-01-03-05:00
0910-0130
201012-0910-005
0910
"Protection of Human Subjects; Recordkeeping Requirements for Institutional Review Boards (IRBs)"
Section 56.115 specifies the types of records to be maintained by institutional review boards which could be subject to review by an investigator.
2014-04-30-04:00
Active
Eliazabeth
Berbakos
3018271482
No
No
No
36500
3650000
0
Protection of Human Subjects; Recordkeeping Requirements for Institutional Review Boards (IRBs)
No
Health
Public Health Monitoring
Private Sector
36500
3650000
0
2011-04-25-04:00
0910-0131
201307-0910-004
0910
"Agreement for Shipments of Devices for Sterilization"
Nonsterile medical devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are normally considered by the Food and Drug Administration (FDA) to be adulterated and misbranded. FDA regulations established a control mechanism by which firms may manufacture and label medical devices as "sterile" at one establishment and ship the devices in interstate commerce for actual sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms. Manufacturers and sterilizers may sign an agreement containing instructions for maintaining accountability of the number of units in each shipment, acknowledgment that the devices are nonsterile and are being shipped for further processing, and specifications for the product's sterilization processing. This agreement allows the manufacturer to ship adulterated or misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. The agreement must include: (a) Instructions for maintaining accountability of the number of units in each shipment; (b) acknowledgment that the devices are nonsterile, being shipped for further processing; and (c) specifications for sterilization processing. These agreements must be retained for two years, as FDA may review them up to two years after final shipment or delivery of devices.
2016-08-31-04:00
Active
Daniel
Gitteson
daniel.gitteson@fda.hhs.gov
3017965156
No
No
No
1800
8100
0
Agreement for Shipments of Devices for Sterilization
No
Health
Consumer Health and Safety
Private Sector
1800
8100
0
2013-08-16-04:00
0910-0133
201108-0910-008
0910
"Temporary Marketing Permit Applications"
Section 401 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 341), directs FDA to issue regulations establishing definitions and standards of identity for food whenever * * * such action will promote honesty and fair dealing in the interest of consumers * * *." Under section 403(g) of the act (21 U.S.C. 343(g)), a food that is subject to a definition and standard of identity prescribed by regulation is misbranded if it does not conform to such definition and standard of identity. Section 130.17 (21 CFR 130.17) provides for the issuance by FDA of temporary marketing permits that enable the food industry to test consumer acceptance and measure the technological and commercial feasibility in interstate commerce of experimental packs of food that deviate from applicable definitions and standards of identity. Section 130.17(c) enables the agency to monitor the manufacture, labeling, and distribution of experimental packs of food that deviate from applicable definitions and standards of identity. The information so obtained can be used in support of a petition to establish or amend the applicable definition or standard of identity to provide for the variations. Section 130.17(i) specifies the information that a firm must submit to FDA to obtain an extension of a temporary marketing permit.
2014-09-30-04:00
Active
Denver
Presley
3018271462
No
No
No
28
654
0
Reporting-21-CFR 130.17 ( c ) - Format and Information for Temporary Marketing Permit Request
No
Health
Consumer Health and Safety
Private Sector
26
650
0
Reporting - 21 CFR 130.17 (i) - Format and Information for Temporary Marketing Permit Extension
No
Health
Consumer Health and Safety
Private Sector
2
4
0
2011-09-27-04:00
0910-0138
201207-0910-010
0910
"Reclassification Petitions for Medical Devices"
This colection requires device manufacturers to provide, in a petition for device reclassification, specification of the type of device, a statement of the action requested, and a justification for the request to reclassify.
The classification regulation, 21 CFR Part 860 including subpart C, reclassification, was promulgated under the authority of 21 U.S.C. 360(e) and (f), 360d(b), 360e(b), 360j(1), and 360i(b)(1)(A).
The staff of the Center for Devices and Radiological Health (CDRH) is responsible for reviewing petitions for reclassification and determining whether the subject device will be reclassified. In some instances, FDA also submits such petitions to one of its medical device advisory panels for review and recommendations. FDA's decision regarding the reclassification of a device is based primarily upon the information contained in the petition.
2015-06-30-04:00
Active
Daniel
Gitteson
daniel.gitteson@fda.hhs.gov
3017965156
No
No
No
6
3000
0
Reclassification Petitions for Medical Devices
No
Health
Consumer Health and Safety
3429
FDA Form 3429
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 3429 7-24-12.doc
3427
FDA Form 3427
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 3427 Final.pdf
Private Sector
6
3000
0
2012-07-31-04:00
0910-0139
201109-0910-005
0910
"Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals"
The CGMP regulations help ensure that drug products meet the statutory requirements for safety and have their purported or represented identity, strength, quality, and purity characteristics. The information collection requirements in the CGMP regulations are necessary to establish accountability in the manufacturing and processing of drug products, provide for meaningful FDA inspections, and enable manufacturers to improve the quality of drug products over time. The CGBP recordkeeping requirements also serve as crucial information if it is necessary to recall a drug product.
2015-04-30-04:00
Active
Johnny
Vilela
juanmanuel.vilela@fda.hhs.gov
301 796-3792
No
No
No
1248727
848625
0
Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals
No
Health
Public Health Monitoring
Private Sector
1248727
848625
0
2012-04-09-04:00
0910-0152
201104-0910-010
0910
"Current Good Manufacturing Practice Regulations for Medicated Feed, 21 CFR Part 225"
These recordkeeping requirements apply to medicated feeds produced by licensed and non-licensed feed manufacturers, both commercial feed mills and mixer-feeders. This information is needed so that FDA can monitor drug usage and possible mis-formulation of medicated feeds to investigate violative drug residues in products from treated animals and to investigate product defects when a drug is recalled.
2014-06-30-04:00
Active
Johnny
Vilela
juanmanuel.vilela@fda.hhs.gov
301 796-3792
No
No
No
33893440
7138800
0
Current Good Manufacturing Practice Regulations for Medicated Feed, 21 CFR Part 225
No
Health
Consumer Health and Safety
Private Sector
33893440
7138800
0
2011-06-27-04:00
0910-0154
201104-0910-012
0910
"Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226"
A "Type A" medicated article is a feed product containing a concentrated drug, diluted with a feed carrier substance. Medicated feeds are administered to animals for prevention, mitigation, or treatment of disease or for growth promotion and feed efficiency.
2014-06-30-04:00
Active
Johnny
Vilela
juanmanuel.vilela@fda.hhs.gov
301 796-3792
No
No
No
150650
157550
0
226.42 - Recordkeeping
No
Health
Consumer Health and Safety
Private Sector
29900
22425
0
226.58 - Recordkeeping
No
Health
Consumer Health and Safety
Private Sector
29900
52325
0
226.80 - Recordkeeping
No
Health
Consumer Health and Safety
Private Sector
29900
22425
0
226.102 - Recordkeeping
No
Health
Consumer Health and Safety
Private Sector
29900
52325
0
226.110 - Recordkeeping
No
Health
Consumer Health and Safety
Private Sector
29900
7475
0
226.115 - Recordkeeping
No
Health
Consumer Health and Safety
Private Sector
1150
575
0
2011-06-27-04:00
0910-0167
201106-0910-010
0910
"Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)"
This information is required in the implementation and administration of the Orphan Drug Act, 21 U.S.C., Sections 526-528. The information is necessary to show that applicants qualify and continue to qualify for the incentives and assistance provided by the statute and regulations.
2014-10-31-04:00
Active
Jonnalynn
Capezzuto
3018274659
No
No
No
2183
69726
0
Written recommendations; content and format of a request, the providing of; refusal to provide
No
Health
Immunization Management
Private Sector
2
200
0
Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation
No
Health
Immunization Management
FDA3671
Common EMEA/FDA Application for Orphan Medicinal Product Designation
Yes
Yes
Fillable Fileable Signable
Form and instruction
FDA 3671.pdf
Private Sector
428
64200
0
Permanent resident agent for foreign sponsor
No
Health
Immunization Management
Private Sector
55
110
0
Changes in ownership of orphan drug designation
No
Health
Immunization Management
Private Sector
43
215
0
Annual reports of holder of orphan drug designation
No
Health
Consumer Health and Safety
Private Sector
1652
4956
0
Insufficient quantities of orphan drugs
No
Health
Consumer Health and Safety
Private Sector
3
45
0
Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)
No
Health
Consumer Health and Safety
FDA 3671
COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PRODUCT DESIGNATION
No
No
Paper Only
Form and instruction
Final version of Common EMEA-FDA Application Form for Orphan Medicinal Product designationFINAL FORM.doc
Private Sector
0
0
0
2011-10-31-04:00
0910-0183
201203-0910-006
0910
"General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions"
The Administrative Procedures Act (5 U.S.C. 553(e)) provides that every Agency shall give an interested person the right to petition for issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30) sets forth the format and procedures by which an interested person may submit to FDA, in accordance with Sec. 10.20 (21 CFR 10.20) (submission of documents to Division of Dockets Management), a citizen petition requesting the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action.
2014-06-30-04:00
Active
ILa
Mizrachi
ila.mizrachi@fda.hhs.gov
301 796-7726
No
No
No
220
5122
0
Citizen Petition
No
Health
Consumer Health and Safety
Private Sector
207
4968
0
Administrative Reconsideration of Action
No
Health
Consumer Health and Safety
Private Sector
4
40
0
Administrative Stay of Action
No
Health
Consumer Health and Safety
Private Sector
5
50
0
Advisory Opinions
No
Health
Consumer Health and Safety
Private Sector
4
64
0
2012-06-11-04:00
0910-0184
201203-0910-010
0910
"Filing Objections and Requests for a Hearing on a Regulation or Order"
The regulations in 21 CFR 12.22, issued under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e)(2)), set forth the instructions for filing objections and requests for a hearing on a regulation or order under Sec. 12.20(d). Objections and requests must be submitted within the time specified in Sec. 12.20(e). Each objection, for which a hearing has been requested, must be separately numbered and specify the provision of the regulation or the proposed order. In addition, each objection must include a detailed description and analysis of the factual information and any other document, with some exceptions, supporting the objection.
2015-06-30-04:00
Active
ILa
Mizrachi
ila.mizrachi@fda.hhs.gov
301 796-7726
No
No
No
3
60
0
Filing Objections and Requests for a Hearing on a Regulation or Order
No
General Government
Legislative Functions
Individuals or Households
3
60
0
2012-06-11-04:00
0910-0186
201207-0910-013
0910
"Irradiation in the Production, Processing and Handling of Food"
Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s) and 348), food irradiation is subject to regulation under the food additive premarket approval provisions of the act. The regulations providing for uses of irradiation in the production, processing, and handling of food are found in part 179 (21 CFR part 179). To ensure safe use of a radiation source, ? 179.21(b)(1) requires that the label of sources bear appropriate and accurate information identifying the source of radiation and the maximum (or minimum and maximum) energy of radiation emitted by x-ray tube sources. Section 179.21(b)(2) requires that the label or accompanying labeling bear adequate directions for installation and use and a statement supplied by FDA that indicates maximum dose of radiation allowed. Section 179.26(c) requires that the label or accompanying labeling bear a logo and a radiation disclosure statement. Section 179.25(e) requires that food processors who treat food with radiation make and retain, for 1 year past the expected shelf life of the products up to a maximum of 3 years, specified records relating to the irradiation process (e.g., the food treated, lot identification, scheduled process, etc.)
2015-08-31-04:00
Active
Domini
Bean
domini.bean@fda.hhs.gov
301 796-5733
No
No
No
1020
1020
0
Irradiation in the Production, Processing and Handling of Food
No
Health
Consumer Health and Safety
Private Sector
900
900
0
Irradiation in the Production, Processing and Handling of Food
No
Health
Consumer Health and Safety
Private Sector
120
120
0
2012-08-31-04:00
0910-0188
201108-0910-013
0910
"Infant Formula Recall Regulations"
Information required to conduct effective recalls of infant forumula.
2014-10-31-04:00
Active
Denver
Presley
3018271462
No
No
No
10
12854
0
Reporting: Requirements for Written Recall Strategy Furnished to Appropriate FDA District Office By Recalling Firm
No
Health
Consumer Health and Safety
Private Sector
2
8900
0
Reporting: Notification , Written Reports & Status Update Requirements for Recalling Firms or Establishments
No
Health
Consumer Health and Safety
Private Sector
2
2964
0
Reporting: Recommendation Requirements for Terminating a Recall by Recalling Firm
No
Health
Consumer Health and Safety
Private Sector
2
240
0
Reporting: Requirements For Additional Effectiveness Checks when Recall Implementation Is Determined Deficient
No
Health
Consumer Health and Safety
Private Sector
1
625
0
Third- Party Disclosure- Notification and Posting Requirements of Recall by Recalling Firm
No
Health
Consumer Health and Safety
Private Sector
2
100
0
Third- Party Disclosure- Additional Notification Requirements When Implementation of Recall Strategy is Determined Deficient
No
Health
Consumer Health and Safety
Private Sector
1
25
0
2011-10-23-04:00
0910-0191
201203-0910-008
0910
"Notice of Participation"
Section 12.45 (21 CFR 12.45) issued under section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets forth the format and procedures for any interested person to file a petition to participate in a formal evidentiary hearing, either personally or through a representative. Section 12.45 requires that any person filing a notice of participation state their specific interest in the proceedings, including the specific issues of fact about which the person desires to be heard. This section also requires that the notice include a statement that the person will present testimony at the hearing and will comply with specific requirements in 21 CFR 12.85, or, in the case of a hearing before a Public Board of Inquiry, concerning disclosure of data and information by participants (21 CFR 13.25). In accordance with sec. 12.45(e) the presiding officer may omit a participant's appearance.
2015-06-30-04:00
Active
ILa
Mizrachi
ila.mizrachi@fda.hhs.gov
301 796-7726
No
No
No
4
12
0
Notice of Participation
No
General Government
Legislative Functions
Private Sector
4
12
0
2012-06-11-04:00
0910-0206
201207-0910-005
0910
"Request for Samples and Protocols"
FDA may at any time require manufacturers of licensed biological products to submit to FDA samples of any lot with the protocols showing the results of the applicable tests prior to distributing the lot of the product. Samples and protocols are required by FDA to help ensure the safety, purity and potency of the product because of thdue to the potential of lot-to-lot variability of a product produced from living organisms.
2015-11-30-05:00
Active
ILa
Mizrachi
ila.mizrachi@fda.hhs.gov
301 796-7726
No
No
No
6827
20572
0
Section 610.2 -- Requests for Samples and Protocols
No
Health
Consumer Health and Safety
Private Sector
6782
20346
0
Section 660.6(b) - Protocols
No
Health
Consumer Health and Safety
Private Sector
43
215
0
Section 660.36(a)(2) and (b) - Samples and Protocols
No
Health
Consumer Health and Safety
Private Sector
1
6
0
Section 660.46(b) - Request for Samples and Protocols
No
Health
Consumer Health and Safety
Private Sector
1
5
0
2012-11-26-05:00
0910-0212
201206-0910-010
0910
"Regulations Under the Federal Import Milk Act "
The Federal Import Milk Act prohibits the imporation of milk and cream into the United States unless the shipper holds a valid Import Milk permit from the Food and Drug Administration. The act requires that all cows be healthy and that the dairy farm and processing plant be in good sanitary condition.
2015-08-31-04:00
Active
Domini
Bean
domini.bean@fda.hhs.gov
301 796-5733
No
No
No
410
609
0
Regulations Under the Federal Import Milk Act
No
Health
Consumer Health and Safety
FDA1996
Dairy Farm Sanitation Report
Yes
Yes
Paper Only
Form and instruction
0212 FDA1996.pdf
Private Sector
400
600
0
Regulations Under the Federal Import Milk Act
No
Health
Consumer Health and Safety
FDA1995
Physical examination of cows
Yes
Yes
Paper Only
Form and instruction
0212 FDA1995.pdf
Private Sector
1
1
0
Regulations Under the Federal Import Milk Act
No
Health
Consumer Health and Safety
FDA1994
Tuberculin Test
Yes
Yes
Paper Only
Form and instruction
0212 FDA1994.pdf
Private Sector
1
1
0
Regulations Under the Federal Import Milk Act
No
Health
Consumer Health and Safety
FDA1997
Sanitary inspections of plants
Yes
Yes
Paper Only
Form and instruction
0212 FDA1997.pdf
Private Sector
2
4
0
Regulations Under the Federal Import Milk Act
No
Health
Consumer Health and Safety
FDA1993
Application for permit
Yes
Yes
Paper Only
Form and instruction
0212 FDA1993.pdf
Private Sector
2
1
0
Regulations Under the Federal Import Milk Act
No
Health
Consumer Health and Safety
FDA1815
Permits granted on certificates
Yes
No
Paper Only
Form and instruction
0212 FDA1815.pdf
Private Sector
2
1
0
Regulations Under the Federal Import Milk Act
No
Health
Consumer Health and Safety
Private Sector
2
1
0
2012-08-31-04:00
0910-0216
201102-0910-011
0910
"Color Additive Requests and Recordkeeping"
FDA has regulatory oversight for color additives used in foods, drugs, cosmetics and medical devices. Section 721(a) of the Federal Food Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a) provides that a color additive shall be deemed unsafe unless it meets the requirement of a listing regulation including any requirement for batch certification and is used in accordance with the regulation. FDA lists color additives that have been shown to be safe for their intended uses in Title 21 of the Code of Federal regulations.( CFR). FDA requires batch certification for all color additives provisionally listed in 21 CFR part 82. Color additives listed in 21 CFR part 73 are exempted from certification. The requirements for color additive certification are described in 21 CFR part 80.
2014-04-30-04:00
Active
Denver
Presley
3018271462
No
No
No
17760
2782
0
Reporting - 21CFR 80.21- Color Additive Certification
No
Health
Consumer Health and Safety
3000
Color Certification Online
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 3000.doc
Yes
No
Printable Only
Instruction
Form FDA 3000 Instructions ( User Guide).pdf
Private Sector
5920
1006
0
Reporting 21 CFR 80.22 - Color Additive Certification
No
Health
Consumer Health and Safety
3000
Color Certification Online
Yes
Yes
Fillable Printable
Form and instruction
Form FDA 3000.doc
Yes
No
Printable Only
Instruction
Form FDA 3000 Instructions ( User Guide).pdf
Private Sector
5920
296
0
Recordkeeping 21 CFR 80.39- Color Additive Certification
No
Health
Consumer Health and Safety
Private Sector
5920
1480
0
2011-04-25-04:00
0910-0230
201207-0910-003
0910
"Adverse Drug Experience Reporting"
Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act require that marketed drugs be safe and effective. In order to know whether drugs that are not safe and effective are on the market, FDA must be promptly informed of adverse experiences occasioned by the use of marketed drugs. In order to help ensure this, FDA issued regulations at 21 CFR 310.305 and 314.80 to impose reporting and recordkeeping requirements on the drug industry that would enable FDA to take action necessary for protection of the public health from adverse drug experiences.
2015-08-31-04:00
Active
Johnny
Vilela
juanmanuel.vilela@fda.hhs.gov
301 796-3792
No
No
No
415226
7312076
47000
Adverse Drug Experience Reporting -- 310.305(c)(5)
No
Health
Public Health Monitoring
Private Sector
3
3
0
Adverse Event Reporting--314.80(c)(1)(iii)
No
Health
Public Health Monitoring
Private Sector
5
5
0
Adverse Event Reporting -- 314.80(c)(2)
No
Health
Public Health Monitoring
Private Sector
15195
911700
25000
Adverse Event Recordkeeping -- 310.305(f)
No
Health
Public Health Monitoring
Private Sector
25
400
0
Adverse Drug Event Recordkeeping -- 314.80(i)
No
Health
Public Health Monitoring
Private Sector
399998
6399968
22000
2012-08-15-04:00
0910-0231
201311-0910-010
0910
"Premarket Approval of Medical Devices - 21 CFR Part 814"